FDA Approves First Drug for Hypoactive Sexual Desire Disorder in Women
The FDA has approved Addyi (flibanserin), the first drug for the treatment of generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
While Addyi is a serotonin 1A receptor agonist and serotonin 2A receptor antagonist, the mechanism by which the drug improves sexual desire is not known.
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Its effectiveness was evaluated in 3 24-week randomized, double-blind, placebo-controlled trials involving approximately 2400 women with generalized HSDD. Sexual desire was scored on a range of 1.2 to 6, and the number of satisfying sexual events was also recorded.
On average, Addyi was found to increase the number of satisfying sexual events by 0.5 to 1 per month, compared with placebo, increased sexual desire by 0.3 to 0.4 compared to placebo, and reduced distress score related to sexual desire by 0.3 to 04 compared to placebo.
Addyi carries a boxed warning concerning severe hypotension and syncope when the drug is combined with alcohol, CYP3A4 inhibitors, and in patients with liver impairment. For these reasons, Addyi will only be available by prescription, and not over-the-counter.
The drug has also been approved with a risk evaluation and mitigation strategy, requiring prescribers and pharmacists to be certified through the program and to counsel patients on the dangers of Addyi when combined with alcohol using a patient-provider agreement form,
Common side effects include dissiness, sleepiness, nausea, fatigue, insomnia, and dry mouth.
—Michael Potts
Reference:
FDA. FDA approves first treatment for sexual desire disorder [press release]. August 18, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm.